Category: St. Jude MedicalSyndicate content

Goldman pans Wall Street's med-tech estimates

January 19, 2012 by MassDevice staff

Goldman Sachs analyst David Roman says Wall Street's consensus estimates for med-tech companies are too high.

MassDevice.com Wall Street Beat

Wall Street's overall take on sales and earnings forecasts for medical device makers this year is too high, according to Goldman Sachs (NYSE:GS) analyst David Roman, who sees The Street's 4th-quarter top-line estimates as split evenly among companies with upside and downside.

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FDA's Shuren talks regulatory reform on Cali tour | MassDevice.com On Call

January 19, 2012 by MassDevice staff

The FDA's medical devices chief Jeffrey Shuren outlines his efforts at reforming the agency's medical device review process as he travels through California.

MassDevice On Call

MASSDEVICE ON CALL — FDA medical device review chief Jeffrey Shuren laid out efforts at addressing device makers' concerns as he toured life sciences hubs in California.

Stops on his tour included a visit to NuVasive (NSDQ:NUVA) in San Diego, whose CEO Alex Lukianov had announced just days prior that FDA delays were costing the company about $70 million each year.

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St. Jude's Fame II FFR trial halted on positive results

January 18, 2012 by MassDevice staff

St Jude Medical's Fame II trial, studying its fractional flow reserve-measuring technology, is halted after showing positive results in a development that could be a boon for STJ, its main competitor in the FFR market and for the drug-eluting stent market.

Fractional flow reserve

St. Jude Medical (NYSE:STJ) said it's halting its Fame II trial after an independent safety advisory board recommended the trial be stopped due to strong positive results.

I-Flow sues doc for off-label use of pain pump | MassDevice.com On Call

January 18, 2012 by MassDevice staff

Kimberly-Clark subsidiary I-Flow sues a Kentucky doctor for off-label use of a pain pump that that allegedly injured a patient.

MassDevice On Call

MASSDEVICE ON CALL — Kimberly-Clark subsidiary I-Flow filed a lawsuit against Kentucky surgeon Dr. Bruce Holladay for off-label use of a pain pump that allegedly resulted in injury to a patient, raising the spectre of a slippery slope of physicians held liable in patient injury lawsuits.

Holladay performed reconstructive surgery on a patient in 2007, implanting a pain pump in the patient's shoulder. When the patient later complained of shoulder pain, he was diagnosed with chondrolysis, a condition in which continuous administration of certain anesthetics can result in the destruction of cartilage.

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Cardiovascular leaders to huddle on Riata recall

January 13, 2012 by MassDevice staff

Physicians from the Minneapolis Heart Institute Foundation and Mayo Clinic organize a one-day summit in the Twin Cities to focus on the recall of St. Jude Medical's Riata leads.

Riata Lead Summit

Physicians from the Minneapolis Heart Institute Foundation and the Mayo Clinic will huddle with electro-physiologists in the Twin Cities Jan. 20 to discuss strategies for dealing with the recall of the Riata defibrillator leads made by St. Jude Medical Inc. (NYSE:STJ).

The FDA slapped the St. Paul, Minn.-based cardiology device maker with a Class 1 recall for the Riata leads in December, after the company said they failed more frequently than previously reported.

MassDevice.com +3 | BSX aims for double-digit EPS growth, St. Jude's Libra helps Parkinson's patients, Judge grants ex-Stryker Biotech exec's request to sever charges in fraud case

January 11, 2012 by MassDevice staff

The top three medical device stories for January 11, 2012.

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com's coverage highlights our three biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you're still in the know with MassDevice +3.

St. Jude's Libra helps patients with Parkinson's

January 11, 2012 by MassDevice staff

Deep brain stimulation systems from St. Jude Medical helps manage symptoms of Parkinson's disease, study says.

A deep brain stimulation implant made by St. Jude Medical's (NYSE:STJ) proved effective in the treatment of patients Parkinson's disease, according to results published in The Lancet.

The 136-patient study compared patients suffering from Parkinson's who were implanted with St. Jude's Libra and LibraXP DBS systems with and without stimulation. The study enrolled patients who had suffered from Parkinson's for at least 5 years, or who had 6 hours a day with diminished motor symptom control and muscle ticks.

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